盐酸维拉帕米注射液的含量及有关物质的HPLC测定

HPLC determination of verapamil HCI and its related substances

目的:建立测定盐酸维拉帕米注射液含量及有关物质的HPLC法。方法:采用Phenomenex ODS-3C18柱,(150mm×4.6mm,5μm),甲醇:醋酸-醋酸钠-三乙胺溶液(取醋酸钠1.36g,加水适量,摇振使溶解,加冰醋酸33mL,三乙胺20mL,加水稀释至1000mL,摇匀)(58∶42)为流动相,检测波长为278nm;流速:1.0mL.min-1。结果:盐酸维拉帕米在浓度67.4~115.56μg.mL-1范围内线性关系良好,相关系数r=0.9999。平均回收率:99.90%,RSD=0.22%。结论:本方法快速,准确,可作为盐酸维拉帕米注射液的质控标准。

Objective:To establish a HPLC method for determination of verapamil HCI and its related substances.Methods:Chromatographic conditions:column:Phenomenex ODS-3 C column(150mm×4.6mm,5μm)mobile phase:methol∶acetic acid-sodium acetate-triethylamine(dissolve1.36g sodium acetate in water with stirring and add 33mL of acetic acid,20mL of triethylamine,diluted to 1 000mL with water,mix well)=58∶42 with a flow rate of 1.0mL·min-1;detector:UV detector at 278nm.Results:A linear range of 67.4~115.5.6μg·mL-1(γ=0.999 9)with a RSD of 0.22 and a precision of 99.90%,were obtained.Conclusion:A rapid and accurate HPLC method for control of the quality of verapamil HCI Injection is established.